PMDA drug package insert
ミカルディス錠20mg
PMDA Prescription drug · 日本ベーリンガーインゲルハイム株式会社 · package insert Sep 9, 2025
Key facts
| Brand names | ミカルディス錠20mg, ミカルディス錠40mg, ミカルディス錠80mg |
|---|---|
| Nonproprietary names | テルミサルタン |
| Companies | 製造販売元／日本ベーリンガーインゲルハイム株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 胆汁排泄型持続性AT1受容体ブロッカー |
| Therapeutic category codes | 872149 |
| YJ codes | 2149042F1025, 2149042F2021, 2149042F3028 |
| Approval numbers | 21600AMZ00541000, 21600AMZ00542000, 22200AMX00375000 |
| Package insert edition | 第3版 |
| Package insert date | Sep 9, 2025 |
| PMDA document key | 650168_2149042F1025_1 |
| PMDA company code | 650168 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 Safety communications
- Yes PMDA review report published
- No Risk management plan (RMP)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA approved drugs and package inserts (Japan)
Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date: